CClinicalTrials.gg
CompletedNCT03849547Updated Feb 17, 2020

Evaluation for the Effect of Smartphone Based Training on Chronic Ankle Instability Subjects

An interventional study of App Balance training and Home Balance training in Chronic Ankle Instability, sponsored by National Yang Ming Chiao Tung University. Completed at 1 site in Taiwan. Open to participants aged 20 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-02-17.

Sponsored by National Yang Ming Chiao Tung University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
46
Allocation
Randomized
Ages
20 Years to 65 Years
Sex
All
01

Study summary

This study aims to verify the training effect of smartphone-based training for chronic ankle instability(CAI) subjects. By randomizing subjects to App training group, clinical training group and control group, the training effect will be compared among groups.

Read the detailed description

Postural control ability may be damaged after ankle sprains. Poor postural control ability is the risk factors of the ankle sprain, forming a vicious circle of recurrent sprains. Proper and early assessment is the key to breaking down the circle. Smartphones have been utilized in the medical field. With built-in sensors, utilizing smartphones as assessment tools can provide quantitative data of postural control performance. This study aims to verify the training effect of smartphone-based training for CAI subjects.

CAI subjects were recruited and randomly assigned to App training group, Home training group and control group, receiving 6 weeks of intervention. Pre-test was conducted before the intervention, and the post-test was conducted after the 6-week intervention. The follow up assessment was conducted 4 weeks after the post-test.

02

Conditions studied

  • Chronic Ankle Instability

Keywords

  • Chronic ankle instability
  • Smartphone
03

In context

Lead sponsor

National Yang Ming Chiao Tung University is the lead sponsor of 201 studies on the registry; 58 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • At least one ankle sprain history
  • At least 2 times of sprain and feeling unstable
  • Diagnosed as functional ankle instability
  • Full recovered from injury
  • Cumberland Ankle Instability Tool\<24
  • Ankle Instability Instrument >5 yes
  • Identification of Functional Ankle Instability >11

Exclusion criteria

Exclusion Criteria:

  • Diagnosis as mechanical instability
  • Neurological deficits
  • Lower extremity injury within the past 6 wk
  • History of lower-extremity surgery
  • Other conditions known to affect balance
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
46 participants (actual)

Study arms

  • Experimental
    App training group

    Subjects in App training group will receive App Balance training via smartphone application.

    Other: App Balance training

  • Active comparator
    Home training group

    Subjects in Home training group will receive Home Balance training advised by physical therapist.

    Other: Home Balance training

  • No intervention
    Control group

    Control group will receive only education of ankle injury prevention related information.

Interventions

  • OtherApp Balance training

    Training specially designed for balance ability of chronic ankle instability groups. Guidance through smartphone application as home program.

  • OtherHome Balance training

    Training specially designed for balance ability of chronic ankle instability groups. Follow the usual home program provided in clinics.

06

What researchers measure

Primary outcomes

  1. Postural sway measurement

    Using smartphone application and force plate to record the postural sway during single leg stance.

    Time frame: 30 seconds

  2. Star Excursion Balance Test

    To assess the dynamic balance ability of subjects.

    Time frame: 5 minutes

Secondary outcomes

  1. Foot and Ankle Outcome Score

    An ankle function assessment tool, with 5 dimensions includes symptoms, pain, activity, function and sport, and quality of life. The scale score ranges from 0% to 100%, the higher the percentage, the better ankle function. Subjects answer the questions by choosing different choices that describe their condition the best. The total score will be summed up and calculated as percentage.

    Time frame: 5 minutes

  2. Foot and Ankle Ability Measure-sport subscale

    An ankle function assessment tool. The scale score ranges from 0% to 100%, the higher the percentage, the better ankle function. Subjects answer the 7 questions by choosing different degree of difficulty to accomplish the activities. The total score will be summed up and calculated as percentage.

    Time frame: 5 minutes

07

Study locations

1 site
  • Yang Ming university
    Taipei, Taiwan
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 17, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03849547
Lead sponsor
National Yang Ming Chiao Tung University
Responsible party
Wen-Hsu Sung (Professor, National Yang Ming Chiao Tung University) — Principal investigator
First posted
Feb 21, 2019
Start date
Feb 18, 2019
Primary completion
Jan 15, 2020
Completion
Jan 31, 2020
Last update
Feb 17, 2020

Study contacts

Wen-Hsu Sung, Dr.
study chair · National Yang Ming Chiao Tung University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion